(72 days)
Not Found
No
The description focuses on the material properties and function of a wound dressing, with no mention of AI or ML.
No.
The device is a wound dressing which absorbs exudate and helps with the healing process by providing a moist environment. While it aids in healing, it is not described as directly administering therapy or otherwise treating a disease state.
No
The device is described as a wound dressing which aids in healing by creating a moist environment and controlling minor bleeding, not for diagnosing conditions.
No
The device description clearly states it is a nonwoven dressing made from calcium alginate, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing applied externally to wounds to manage exudate and aid healing. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical properties and function of the dressing as a material that interacts with wound exudate on the surface of the wound. It does not describe any testing or analysis of biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
MAY 2 7 1998
Image /page/0/Picture/2 description: The image shows the letters "IT" next to a circular logo. The logo is divided into two halves, with the top half being white and the bottom half being black. A cross is centered in the circle, with the top of the cross extending into the white half and the bottom of the cross extending into the black half. The letters "IT" are in a bold, sans-serif font.
Innovative Technologies Ltd
Summary of Safety and Effectiveness for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing
Manufacturer:
Regulatory Affairs Contact:
Telephone:
Date Summary Prepared:
Device Trade Name:
Common or Usual Name:
Classification:
Description:
Intended Use:
Substantial Equivalence:
Testing Summary:
Innovative Technologies, Limited Road Three. Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom
Priscilla Whitehead Cox, Manager
44 1606 863 500
March 2. 1998
3M™ Tegagen™ HI Alginate Dressing , Product Number 901XX Series and 3M™ Tegagen™ HG Alginate Dressing, Product Number 902XX Series.
Alginate Wound Dressings
Wound Dressings, currently unclassified by FDA.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
Tegagen HI and Tegagen HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate. They may be used for pressure ulcers, arterial ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, and other dermal lesions. They also are intended to help control minor bleeding. This product is not designed, sold, or intended for use except as indicated.
Substantial equivalence was provided in 510(k) K953781.
Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use.
Image /page/0/Picture/28 description: The image shows a logo with the letters "BSI" in the center, above a heart shape with a horizontal line through it. The letters "AE" are on the left side of the logo, and the letters "ME" are on the right side. The logo is black and white and has a circular shape.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.
MAY 2 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris J. Oakes Regulatory Affairs Manager Innovative Technologies Limited Road Three, Winsford Industrial Estate Winsford, Cheshire CW7 3PD, United Kingdom
Re: K980989 Trade Name: 3M Tegagen HI and HG Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: March 2, 1998 Received: March 16, 1998
Dear Mr. Oakes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
2
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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11980989 510(k) Number (if known):
Device name: 3M Tegagen HI & 3M Tegagen HG Alginate Dressings
Indications For Use:
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over The Counter Use |
|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980989 |
RH, Office of Device Examation (ODE) ﺗﺎ